BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3024247 · Received March 27, 2013

    Report

    Report Number
    2531779-2013-03164
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    March 3, 2013
    Report Date
    March 3, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT CONTACTED ANIMAS AND ALLEGED THE FOLLOWING: SHE WAS HOSPITALIZED FOR HYPOGLYCEMIA AFTER THE PUMP INFUSED 60 UNITS OF INSULIN INTO HER ON ITS OWN. THE PATIENT STATES THAT SHE HAD CHANGED HER CARTRIDGE AND THEN GIVEN HERSELF A 5 UNIT BOLUS. THEN HER BG DROPPED DOWN TO 37MG/DL AND SHE WAS WEAK, SWEATY, NAUSEATED, AND VOMITING. SHE THEN REMOVED THE CARTRIDGE AND FOUND THAT THERE WAS ABOUT 60 UNITS MISSING FROM THE CARTRIDGE. SHE WAS TAKEN TO HOSPITAL AND WAS ADMITTED WITH A DIAGNOSIS OF HYPOGLYCEMIA. SHE WAS GIVEN AN IV OF D5 AND STATES HER CURRENT BG IS 147MG/DL. SHE HAD DISCONNECTED FROM THE PUMP AFTER HER BG DROPPED AND DOES NOT HAVE THE PUMP AVAILABLE TO REVIEW AT THIS TIME. THE PATIENT AGREED TO CONTACT CUSTOMER TECHNICAL SUPPORT AFTER DISCHARGE, TO TROUBLESHOOT THE PUMP. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGATION THAT THE PATIENT WAS HOSPITALIZED FOR HYPOGLYCEMIA AFTER PUMP DISPENSED INSULIN WITHOUT USER INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126949 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR